Status: Ongoing
First registered on:
18/07/2012
Last updated on:
01/02/2013
1. Study identification
EU PAS Register NumberEUPAS2807
Official titlePatients treated with antipsychotics. A follow-up study
Study title acronymÍcaro
Study typeObservational study
Brief description of the studyThis study is intended to further explore the metabolic reactions which appear in patients treated with antipsychotic medications; particularly weight gain. The genetic basis of these reactions are a focus of attention; at this regard, a blood sample is taken from each recruited patient.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsCESME
Department/Research groupCentro de Estudios sobre la Seguridad de los Medicamentos
Organisation/affiliationUniversidad de Valladolid
Details of (Primary) lead investigator
Title Professor
Last name Carvajal
First name Alfonso
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)
Countries in which this study is being conducted
National study
Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/01/200927/04/2009
Start date of data collection01/01/201018/03/2010
Start date of data analysis
Date of interim report, if expected
Date of final study report31/12/2013
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government bodyRegional Goverment/ Ministry of Health100
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Carvajal
First name Alfonso
Address line 1Ramón y Cajal 7
Address line 2
Address line 3
CityValladolid
Postcode47005
CountrySpain
Phone number (incl. country code)34-983263021
Alternative phone number
Fax number (incl. country code)34983254924
Public Enquiries
Title Professor
Last name Carvajal
First name Alfonso
Address line 1Ramón y Cajal 7
Address line 2
Address line 3
CityValladolid
Postcode47005
CountrySpain
Phone number (incl. country code)34-983263021
Alternative phone number
Fax number (incl. country code)34983254924
6. Study drug(s) information
Substance class (ATC Code)N05A (ANTIPSYCHOTICS)
7. Medical conditions to be studied
Medical condition(s)No
8. Population under study
Age
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects425
10. Source of data
Is this study being carried out with an established data source?No
Sources of data
Prospective patient-based data collection
11. Scope of the study
What is the scope of the study?
Risk assessment
Drug utilisation study
Effectiveness evaluation
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
To identify some of the genetic polymorphisms related to weight gain in patients treated with antipsychotics. Other objectives are, to further learn and characterize other adverse reactions, the effectiveness of these medications and the way they are being used in a real setting; finally, an intervention to optimize the use of this medication is foreseen.
Are there primary outcomes?Yes
Weight gain > 7% of inicial weight at baseline
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
Several years
15. Data analysis plan
Please provide a brief summary of the analysis method
Risk estimation
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documents
DescriptionDocumentLatest version
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
